Objectives

The efficacy of thrombolytic therapy with tissue plasminogen activator (tPA) is highly time dependent. Although clinical guidelines do not recommend written informed consent as it may cause treatment delays, local policy can supersede and require it. From 2014 to 2017, three out of five public hospitals in Singapore changed from written to verbal consent at different time points. We aimed to examine the association of hospital policy changes regarding informed consent on door-to-needle (DTN) times.

Materials and Methods

Using data from the Singapore Stroke Registry and surveys of local practice, we analyzed data of 915 acute ischemic stroke patients treated with tPA within 3 hours in all public hospitals between July 2014 to Dec 2017. Patient-level DTN times before and after policy changes were examined while adjusting for clinical characteristics, within-hospital clustering, and trends over time.

Results

Patient characteristics and stroke severity were similar before and after the policy changes. Overall, the median DTN times decreased from 68 to 53 minutes after the policy changes. After risk adjustment, changing from written to verbal informed consent was associated with a 5.6 minutes reduction (95% CI 1.1-10.0) in DTN times. After the policy changed, the percentage of patients with DTN ≤60 minutes and ≤45 minutes increased from 35.6% to 66.1% (adjusted OR 1.75; 95% CI 1.12-2.74) and 9.3% to 36.0% (adjusted OR 2.42; 95% CI 1.37-4.25), respectively.

Conclusion

Changing from written to verbal consent is associated with significant improvement in the timeliness of tPA administration in acute ischemic stroke.

中文翻译：

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知情同意政策的改变和中风溶栓的治疗延迟

目标

用组织纤溶酶原激活剂（tPA）进行溶栓治疗的疗效高度依赖时间。尽管临床指南不建议书面知情同意，因为这可能会导致治疗延误，但是可以取代并要求当地的政策。从2014年到2017年，新加坡五分之三的公立医院在不同时间点从书面同意改为口头同意。我们的目的是研究与医院有关在门诊（DTN）时间上知情同意的政策变化的关联。

材料和方法

使用新加坡中风登记处的数据和当地实践调查，我们分析了2014年7月至2017年12月在所有公立医院3小时内接受tPA治疗的915例急性缺血性中风患者的数据。政策变更前后的患者水平DTN时间为在调整临床特征，医院内聚集和随时间变化的趋势时进行检查。

结果

政策改变前后，患者特征和中风严重程度相似。总体而言，政策更改后，DTN中值时间从68分钟减少到53分钟。调整风险后，将DTN时间从书面知情同意改为口头知情同意减少了5.6分钟（95％CI 1.1-10.0）。更改政策后，DTN≤60分钟和≤45分钟的患者比例从35.6％增至66.1％（调整为OR 1.75； 95％CI为1.12-2.74）和9.3％至36.0％（调整为OR 2.42； 95％） CI 1.37-4.25）。

结论

从书面同意改为口头同意与急性缺血性卒中tPA给药及时性的显着改善有关。